NM404 as an Imaging Agent in Patients With NSCLC

NCT00582283 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: CO02505R21CA092412124I-CLR1404
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine imaging characteristics of radiolabelled 131-I-NM404 in ten patients with cancer, including calculations of PKs, radiation dosimetry, biodistribution, and optimal imaging times (part 1 - complete). In addition, specific tumor accumulation and metabolic fate of 131-I-NM404 will be determined in NSCLC tumors collected in 5 patients (part 2 - complete). Lastly, the study will collect preliminary data on imaging NSCLC tumors in up to 12 patients with evaluable disease (part 3 - ongoing).

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent

  The objective of this protocol is to obtain preliminary data on imaging NSCLC tumors. Images with 124I-NM404 will be evaluated by a nuclear medicine consultant, who will be blind to the participants' clinical findings and other radiographic images. The nuclear medicine consultant will independently record his findings, and then compare his results with those obtained by conventional FDG-PET imaging that was done at baseline as part of this study. This comparison will be only qualitative.

  5 days

Secondary Outcomes (1)

• Semi-quantitative lesion scoring to evaluate Tumor biodistribution

  up to 7 days

Study Arms (1)

Diagnostic: iodine I-124 NM404 CT/PET scan

OTHER

Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.

Drug: I124-NM404

Interventions

I124-NM404 DRUG

I-124-NM404

Diagnostic: iodine I-124 NM404 CT/PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented NSCLC with measurable of disease
• Disease is evaluable by CT scan
• At least 18 years old. Women cannot be pregnant or breastfeeding
• Karnofsky score \>/= to 60
• Adequate renal/hepatic function
• Adequate blood cell count levels

You may not qualify if:

• Concomitant infection
• Other active cancers

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator
• Cellectar Biosciences, Inc.: collaborator

Study Sites (1)

University of Wisconsin Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anne M Traynor, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: January 14, 2004
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

US (1)